Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.

Ocular Therapeutix, Inc.153 enrolled

Overview

To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.

Randomized, multi-center, double-masked, vehicle-controlled, Phase 1/2 study to evaluate the safety, tolerability, and efficacy of OTX-CSI in subjects with dry eye disease. The subjects will be followed for approximately 16 weeks after product insertion

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

153

Conditions

Dry Eye Disease

Interventions

OTX-CSIDRUG

OTX-CSI intracanalicular insert

Placebo VehicleOTHER

Hydrogel Vehicle intracanalicular insert

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Dry eye disease diagnosis * VAS eye dryness severity score ≥ 30. Exclusion Criteria: * Are unwilling to discontinue use of contact lenses * Are unwilling to withhold use of artificial tears.

Locations (15)

Ocular Therapeutix, Inc.

Garden Grove, California, United States

Ocular Therapeutix, Inc.

Inglewood, California, United States

Ocular Therapeutix, Inc.

Outcomes

Primary Outcomes

Number of Subjects With At Least One (1) Treatment Emergent Adverse Event

Time frame: From Screening to Study Exit, approximately 156 days.

Schirmer Test Score, CFB at Week 12

A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).

Time frame: Change from Baseline at Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.